Commissioning Qualification Validation Specialist
1 month ago
PSC Biotech is seeking a highly skilled Commissioning Qualification Validation Engineer to join our team. As a key member of our team, you will be responsible for ensuring the highest standards of quality and compliance in our facilities and equipment.
Key Responsibilities- Commission, qualify, and validate GxP facilities, equipment, and utilities in assigned projects.
- Responsible for protocol writing and execution - Draft, execute, review, and approve validation documentation ensuring the documentation meets cGMP requirements, regulatory requirements, and quality standards.
- Draft and execute validation documentation such as: Validation Project & Master Plans, Requirement Specifications (URS, DS, FS), IQ and OQ Test Scripts, IQ/OQ/PQ Protocols, Validation Summary Report, and more.
- Initiate and coordinate risk analyses, design reviews, and execute FAT/SAT, IQ, OQ, and PQ.
- Conduct preventative maintenance and perform risk assessments.
- Recommended process improvements where needed ensuring compliance with industry standards.
- Establish validation standards and develop performance testing and quality control measures.
- Execute process equipment and clean room validation.
- Clearly communicate all progress, updates, and action steps for assigned projects. Collaborate with multiple departments on assigned project activities and deliverables.
- Bachelor's Degree in a relevant science or engineering field, or equivalent years of hands-on experience.
- 3+ years' experience in the biotechnology and pharmaceutical industries with a minimum of 2 years relevant experience performing CQV activities within GMP environment.
- Sound industry knowledge, project proficiency, and autonomy expected.
- Experienced in CQV of facility/utility/equipment, including PW, HVAC and process or laboratory equipment, etc.
- Understands current risk-based validation approaches.
- Experience in authoring, revising, reviewing, and completing controlled documents for validation projects.
- Experience with system impact assessment and risk assessment.
- Good knowledge of the code of GMP and PIC/S code.
- Previous experience in the Life Sciences Industry is required.
- Previous experience in GxP Industries are required.
- Must be adaptable, customer service oriented, have a positive attitude.
- Excellent organizational skills.
- High attention to detail.
- Must have strong written and verbal communication skills.
PSC Biotech offers a competitive compensation and benefits package, as well as opportunities for growth and development. We are committed to providing a work environment that is inclusive, diverse, and supportive of our employees' needs.
We are an equal opportunities employer and welcome applications from all qualified candidates. If you are a motivated and experienced Commissioning Qualification Validation Engineer looking for a new challenge, please submit your application.
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Adelaide, South Australia PSC Biotech Full timeJob Title: Commissioning Qualification Validation EngineerAbout PSC BiotechPSC Biotech is a leading provider of life sciences services, dedicated to ensuring the highest standards of quality and compliance in the development, manufacturing, and distribution of healthcare products. Our global team of experts spans across strategically located offices, and we...
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Adelaide, South Australia PSC Biotech Full timeJob Title: Commissioning Qualification Validation EngineerAbout the RolePSC Biotech is a leading provider of life sciences services, ensuring the highest standards of quality and compliance in the development, manufacturing, and distribution of healthcare products. We are seeking a highly skilled Commissioning Qualification Validation Engineer to join our...
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Adelaide, South Australia PSC Biotech Full timeAbout PSC BiotechPSC Biotech is a leading provider of life sciences services, dedicated to ensuring the highest standards of quality and compliance in the development, manufacturing, and distribution of healthcare products.Job SummaryWe are seeking a highly skilled Commissioning, Qualification, and Validation (CQV) Engineer to join our team. The successful...
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Adelaide, South Australia PSC Biotech Corporation Full timeAbout PSC Biotech CorporationPSC Biotech Corporation is a leading provider of life sciences services, dedicated to ensuring the highest standards of quality and compliance in the development, manufacturing, and distribution of healthcare products.Job SummaryWe are seeking a highly skilled Commissioning, Qualification, and Validation (CQV) Engineer to join...
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Adelaide, South Australia PSC Biotech Full timeAbout PSC BiotechPSC Biotech is a leading provider of life sciences services, dedicated to ensuring the highest standards of quality and compliance in the development, manufacturing, and distribution of healthcare products.Job SummaryWe are seeking a highly skilled Commissioning, Qualification, and Validation (CQV) Engineer to join our team. The successful...
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Adelaide, South Australia PSC Biotech Full timeAbout the RolePSC Biotech is seeking a highly skilled Commissioning, Qualification, and Validation (CQV) Engineer to join our team in an exciting and developing biotechnology landscape.Key ResponsibilitiesCommission, qualify, and validate GxP facilities, equipment, and utilities in assigned projects.Responsible for protocol writing and execution - Draft,...
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Adelaide, South Australia PSC Biotech Full timeAbout the RolePSC Biotech is seeking a highly skilled Commissioning, Qualification, and Validation (CQV) Engineer to join our team in the life sciences industry. As a CQV Professional, you will work closely with our talented team to deliver high-quality projects that meet the highest standards of regulatory compliance.Key ResponsibilitiesCommission, qualify,...
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Adelaide, South Australia PSC Biotech Corporation Full timeAbout PSC Biotech CorporationPSC Biotech Corporation is a leading provider of life sciences services, dedicated to ensuring the highest standards of quality and compliance in the development, manufacturing, and distribution of healthcare products.Job DescriptionWe are seeking a highly skilled Commissioning, Qualification, and Validation (CQV) Engineer to...
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